5820626 Meijer Oral Anesthetic Liquid

5820626 Meijer Oral Anesthetic Liquid
SPL v5
SPL
SPL Set ID 0321c480-e150-421d-e063-6294a90ad687
Route
ORAL
Published
Effective Date 2023-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Benzyl Alcohol Water Polyethylene Glycol 400 D&c Yellow No. 10 Fd&c Blue No. 1 Saccharin Propylene Glycol Methylparaben Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-05

Description

Benzocaine 20.0% (w/w)

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Benzocaine 20.0% (w/w)

Uses

Temporarily relieves pain associated with the following mouth and gum irritations:

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
  • dentures
Section 51945-4

Warnings

METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious confition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use

  • for teething
  • in children under 2 years of age

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a dentist or doctor

Stop use and ask doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops
Directions

Adults and children 2 years of age and older: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist

  • children under 12 years of age: adult supervision should be given in the use of this product
  • children under 2 years of age: do not use
  • for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
Active Ingredient

Benzocaine 20.0% (w/w)

Inactive Ingredients

Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Temporarily relieves pain associated with the following mouth and gum irritations:

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
  • dentures
Section 51945-4 (51945-4)

Purpose

Oral pain reliever

Warnings

METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious confition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use

  • for teething
  • in children under 2 years of age

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a dentist or doctor

Stop use and ask doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops
Directions

Adults and children 2 years of age and older: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist

  • children under 12 years of age: adult supervision should be given in the use of this product
  • children under 2 years of age: do not use
  • for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
Active Ingredient

Benzocaine 20.0% (w/w)

Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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